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A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
Sponsor: Glycyx Therapeutics
Summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TD-1211 in healthy subjects and activity in subjects with opioid-induced constipation (OIC).
Official title: A Phase 1/Phase 2, Randomized, Double-Blind, Multiple Ascending Dose Study to Assess the Safety, Pharmacokinetics, and Effect on Opioid Analgesia of TD-1211 Administered Orally to Healthy Volunteers and to Assess the Safety, Pharmacokinetics, and Effect on Bowel Movements in Subjects With Opioid-Induced Constipation
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
102
Start Date
2010-01
Completion Date
2010-10
Last Updated
2026-05-22
Healthy Volunteers
Yes
Conditions
Interventions
TD-1211
Dose level 1
TD-1211
Dose level 2
TD-1211
Dose level 3
TD-1211
Dose Level 4
TD-1211
Ascending doses
TD-1211
Ascending doses
TD-1211
Ascending doses
TD-1211
Ascending doses
TD-1211
Ascending doses
Placebo
Ascending doses
Locations (3)
Clinical Research Unit
Pasadena, California, United States
Clinical Research Unit
San Antonio, Texas, United States
Clinical Research Unit
Salt Lake City, Utah, United States